Materials and Methods For Treating and Managing Plaque Disease

• US 20080125858A1
• Filed: 12/06/2005
• Published: 05/29/2008
• Est. Priority Date: 12/08/2004
• Status: Abandoned Application

• Current Assignee: Shire Regenerative Medicine Incorporated (Shire plc)
• Original Assignee: Shire Regenerative Medicine Incorporated (Shire plc)
• Inventors: Edelman, Elazer, Nugent, Helen Marie, Bollinger, Steve, Dalal, Anupam
• Application Number:
  US11/792,335
• Publication Number:
  US 20080125858A1
• Time in Patent Office: Days
• US Class Current: 623/1.41
• CPC Class Codes: A61F 2310/00365 Proteins; Polypeptides; Degradation products thereof
• CPC Class Codes: A61L 27/3808 Endothelial cells
• CPC Class Codes: A61P 11/00 Drugs for disorders of the respiratory system
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: A61P 7/02 Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
• CPC Class Codes: A61P 7/04 Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
• CPC Class Codes: A61P 9/00 Drugs for disorders of the cardiovascular system
• CPC Class Codes: A61P 9/08 Vasodilators for multiple indications
• CPC Class Codes: A61P 9/10 for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis

Abstract

Disclosed herein are materials and methods suitable for treating and managing plaque disease, including vulnerable plaque. An implantable material comprising cells, such as but not limited to endothelial cells, and a biocompatible matrix can reduce progression or deterioration of a plaque-associated lesion situated on the interior lumen of said blood vessel. The implantable material is implanted directly on an exterior surface of a blood vessel at or adjacent or in the vicinity of the site of a lesion on an interior lumen. Alternatively, the implantable material is deposited on an exterior surface at or adjacent or in the vicinity of the site of a lesion on an interior lumen by an intraluminal delivery device which traverses or penetrates the vessel wall or by a percutaneous delivery device which enters the perivascular space. Both modes of administration can be preceded by or coincident with an imaging step. The present invention can treat hemorrhage, erosion, fissure, plaque-associated thrombosis and occlusion, rupture, displacement and/or dislodgement of a plaque lesion.

Claims

1. A method of treating a plaque-burdened site, the method comprising the step of:

contacting with an implantable material an exterior surface of a blood vessel at or adjacent or in the vicinity of a plaque-burdened site on an interior lumen of said vessel, wherein said implantable material comprises a biocompatible matrix and cells and wherein said implantable material is in an amount effective to treat the plaque-burdened site.

2. The method of claim 1 wherein said effective amount reduces plaque hemorrhage at the plaque-burdened site.

3. The method of claim 1 wherein said effective amount reduces plaque fissure at the plaque-burdened site.

4. The method of claim 1 wherein said effective amount reduces plaque-associated thrombosis at the plaque-burdened site.

5. The method of claim 1 wherein said effective amount reduces plaque erosion at the plaque-burdened site.

6. The method of claim 1 wherein said effective amount reduces plaque-associated occlusion at the plaque-burdened site.

7. The method of claim 1 wherein said effective amount reduces displacement or dislodgement of plaque at the plaque-burdened site.

11. The method of claim 1, wherein deposition of the implantable material is accomplished by traversing or penetrating an interior wall of said blood vessel and then depositing the implantable material at or adjacent or in the vicinity of the plaque-burdened site.

12. The method of claim 1, wherein deposition of the implantable material is accomplished by entering the perivascular space by percutaneous administration and then depositing the implantable material at or adjacent or in the vicinity of the plaque-burdened site.

13. The method of claim 11 further comprising the step of identifying a site for depositing the implantable material on an exterior surface of said blood vessel.

14. The method of claim 13 wherein the identifying step occurs prior to or coincident with the traversing or penetrating step.

15. The method of claim 13 wherein the identifying step is accomplished by imaging.

16. The method of claim 12 further comprising the step of identifying a site for depositing the implantable material on an exterior surface of said blood vessel.

17. The method of claim 16 wherein the identifying step occurs prior to or coincident with the entering step.

18. The method of claim 16 wherein the identifying step is accomplished by imaging.

19. An implantable material suitable for use with the method of claim 1.

20. The implantable material of claim 19 wherein the implantable material is a flexible planar form.

21. The implantable material of claim 19 wherein the implantable material is a flowable composition.

22. The implantable material of claim 21 wherein the flowable composition is shape-retaining.

23. The implantable material of claim 19 wherein said cells are endothelial cells or cells having an endothelial-like phenotype.

24. The implantable material of claim 23 wherein said cells are selected from the group consisting of:

a confluent population of cells;

a near confluent population of cells;

a post confluent population of cells; and

cells which have a phenotype of any one of the foregoing population of cells.

25. The method of claim 1, wherein the exterior surface of said blood vessel is a non-luminal surface.

26. The method of claim 1, wherein the exterior surface of said blood vessel occupies perivascular space.

27. The method of claim 11 wherein the implantable material is a flowable composition.

8. A method of treating plaque disease, the method comprising the step of:

contacting with an implantable material an exterior surface of a blood vessel at or adjacent or in the vicinity of a lesion on an interior lumen of said vessel, wherein said implantable material comprises a biocompatible matrix and cells and wherein said implantable material is in an amount effective to treat plaque disease.

28. The method of claim 8 wherein the plaque disease is associated with atherosclerosis.

29. The method of claim 8 wherein the plaque is vulnerable or non-vulnerable plaque.

9. A method of treating acute coronary syndrome, the method comprising the step of:

contacting with an implantable material an exterior surface of said blood vessel at or adjacent or in the vicinity of a plaque-burdened site on the interior lumen of said vessel, wherein said implantable material comprises a biocompatible matrix and cells and wherein said implantable material is in an amount effective to reduce the incidence of cardiac events associated with acute coronary syndrome.

10. A method of diminishing clinical sequelae associated with vulnerable plaque, the method comprising the step of:

contacting with an implantable material an exterior surface of said blood vessel at or adjacent or in the vicinity of a plaque-burdened site on the interior lumen of said vessel, wherein said implantable material comprises a biocompatible matrix and cells and wherein said implantable material is in an amount effective to diminish clinical sequelae associated with vulnerable plaque, said clinical sequelae selected from the group consisting of;

acute coronary syndrome, myocardial infarction, sudden cardiac death.